On June 15th at the DIA (Virtual) Annual Meeting, Catalyst’s Nancy Myers moderated a panel titled “Gene Therapy Manufacturing: How Can Innovation Help Overcome This Anticipated Hurdle?” The esteemed panelists were Peter Marks, Director of CBER at FDA; Karen Walker, Senior Adviser on Cell and Gene Therapy at Genentech; and Mark Paglia, SVP of CMC Operations at ElevateBio.
With the rapid innovation and advancements in gene therapy research and development, an increasing number of gene therapy products are in the horizon. The gene therapy wave isn’t all smooth sailing, however, as manufacturing challenges face both the industry and regulators hoping to get these new and effective treatments on the market. As Peter Marks said, “now is the time to get things right.” With more precise and accurate analytics, consistent regulatory review, workforce training, industry collaboration, and public-private partnerships, there can be great progress in gene therapy development.
Read about the gene therapy CMC issues discussed during the DIA panel in this Pink Sheet article (subscription required).